LONDON, Feb 20 (Reuters) - One year on from a breast implantscandal that shook confidence in Europe's light-touch system forregulating medical devices, lawmakers and manufacturers are atloggerheads on ways to protect patients from shoddy products.

Companies that make implantable devices such as new hips andheart stents accept the need for change to the current set-upbut oppose a radical overhaul, arguing that would delay thelaunch of new devices by years and stifle innovation.

The European Commission, the bloc's executive arm, hasproposed a new level of scrutiny, and some members of theEuropean Parliament want a whole new system of pre-marketapproval that would raise the bar still further.

The issue will come to a head at a European Parliamentcommittee on Feb. 26, where officials, industry leaders anddoctors' representatives will argue over the way forward.

Dagmar Roth-Behrendt, the German lawmaker chairing thepanel, is convinced Europe needs a more rigorous system fortesting medical devices before they are approved.

"We absolutely need that," she told Reuters. "We don't needit for every medical device, but for certain medical devices,without any doubt, we need a more stringent prior authorisationsystem."

Like some top doctors, she believes the current system builton around 80 Notified Bodies - mainly private firms scatteredacross Europe - is simply not up to the job.

Panos Vardas, president of the European Society ofCardiology, said there were "major deficiencies" in the currentsystem and a more coordinated approach was vital. Cardiologistsare big users of medical devices, ranging from stents that propopen arteries to pacemakers and artificial heart valves.

The negotiation process between governments, parliament andthe Commission is likely to be lengthy, and new legislation maynot come into force across the EU until as late as 2019.

NEEDLE IN HAYSTACK

Critics say Europe's weak regulation is partly to blame forallowing France's Poly Implant Prothese (PIP) to manufacture forup to a decade substandard silicone breast implants that wereused by hundreds of thousands of women around the world.

But EU trade group Eucomed, representing some 22,500 devicecompanies, argues no system could stop a fraud like PIP. It alsoquestions whether a different regime would have stopped riskymetal-on-metal hip implants reaching the market, given such hipswere also approved under the more stringent U.S. system.

A key debate is whether Europe should shift to a centralisedsystem as in the United States, potentially by folding devicesregulation into the European Medicines Agency (EMA).

EMA boss Guido Rasi, who will address the Feb. 26 meeting,said in an interview last year there was an "urgent need" toregulate devices as tightly as drugs, although whether the EMAshould play a role was up to politicians.

That notion alarms Eucomed's CEO Serge Bernasconi.

"If Europe were to switch to a centralised system, we expectthat, once the new system is up and running, patients willexperience a 3-5 year unnecessary delay in receiving medicaldevices compared to today's situation," he said.

And getting such a system up to speed could cause anadditional delay of one or two years, he added, underminingEurope's leading position in devices innovation.

An analysis by Boston Consulting Group last year foundhigh-tech medical devices were, on average, made available inEurope 43 months before reaching the U.S. market.

The European Commission's answer is to reform the currentdecentralised system by allowing a new Medical DeviceCoordination Group to request additional assessments - such aslonger or larger clinical trials - for some so-called "ClassIII", or high-risk, devices.

Manufacturers, however, fear this approach will be randomand akin to looking for "a needle in a haystack", with littlechance of picking up problems.

The industry backs the Commission's goal of improvingstandards at Notified Bodies, but would rather this was done byselecting only the best ones to approve higher risk devices,rather than introducing an extra layer of scrutiny.

More than 500,000 medical devices are sold in the EU,ranging from bandages, dentures and wheelchairs to pacemakers.

They are regulated under the Conformite Europeenne system, which is also used for gadgets like toasters, though getting a"CE mark" for a medical device is tougher than for suchhousehold appliances.